Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 39

The objectives of this chapter are:

1 To put GCP into perspective with the other GXP. GXP is an acronym for Good Laboratory, manufacturing, and clinical practice requirements that are applicable during the drug development process.

2 To emphasize that clinical development must apply the “good” practices culture which evolved from drug and device manufacturing regulations.

3 To emphasize the importance of the cross connectivity of GXP requirements and the dependence of the overall drug development process on maintaining a compliance mindset while performing all steps, phases, and activities.…